Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Gonal-f
Follitropin alfa liquid formulation · 3 trials · 5 indications
The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.
Number of subjects who self-administered the IMP were presented in this outcome measure.
Convenience parameters included nurse/subjects preference; time to train subject; operative tolerance and wastage of product which were assessed during the post-treatment period. Safety parameters included local reactions (pain, bruising, redness, itching, swelling)and adverse drug events which were assessed during the pre-treatment, treatment and post-treatment period.
| Arm | Type | Description |
|---|---|---|
| Gonal-f® Plus Pergoveris® | ACTIVE_COMPARATOR | - |
| Pergoveris® | EXPERIMENTAL | - |
| GONAL-f® | EXPERIMENTAL | - |
| Gonal-f | EXPERIMENTAL | - |
| Puregon | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Gonal-f® | DRUG | Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5). |
| Pergoveris® | DRUG | Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles \>= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice. |
| Recombinant human chorionic gonadotropin (r-hCG) | DRUG | 250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles \>= 18 mm). |
| Follitropin alfa liquid formulation | DRUG | Follitropin alfa (Gonal-f) liquid pen (300, 450 and 900 IU) was applied by subcutaneous (sc) administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center |
| Follitropin beta liquid formulation | DRUG | Follitropin beta (Puregon) liquid cartridge (300 and 600 IU) used with the Pen was applied by sc administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center |
Inclusion Criteria: * Be a female subject justifying an in vitro fertilization and embryo transfer (IVF/ET) treatment * Be between her 36th and 40th birthday (both included) at the time of the randomization visit * Have early follicular phase (Day 2-4) serum level of basal follicle stimulating horm...